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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: July 13, 2018

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Jury Awards $4.62 Billion in Johnson & Johnson Talcum Powder Lawsuit A jury says Johnson & Johnson must pay $4.62 billion to 22 women who allege they developed ovarian cancer after using the company's Baby Powder and Shower to Shower brand talcum powder as part of their daily feminine hygiene... Read more

Minor Cuts Are Simple to Treat

Posted today in Medical

SUNDAY, July 15, 2018 -- There's no need to panic if you cut yourself with a knife or broken glass, one dermatologist says, since most cuts can be treated at home. "The most important thing to do is to gently wash the cut to prevent an infection," said Dr. Laura Ferris, an associate professor of dermatology at the University of Pittsburgh Medical Center. "Beyond that, most minor cuts and scrapes stop bleeding and... Read more

To Fend Off Migraines, Try Keeping a Headache Diary

Posted yesterday in Medical

SATURDAY, July 14, 2018 -- A migraine diary may help you pinpoint -- and avoid -- headache triggers, a neurologist says. About 12 percent of people in the United States suffer from migraines, according to the Migraine Research Foundation. "A migraine can be debilitating and can impact daily activities, your family and social life. Unfortunately, migraine often goes undiagnosed and undertreated," said Dr. Sait... Read more

FDA Approves TPOXX (tecovirimat) as the First Drug for the Treatment of Smallpox

Posted 2 days ago in New Drug Approvals

July 13, 2018 -- The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon. “To address the risk of bioterrorism, Congress has t... Read more

FDA Announces Voluntary Recall of Several Medicines Containing Valsartan Following Detection of an Impurity

Posted 2 days ago in News for Health Professionals

July 13, 2018 -- The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being... Read more

Jury Awards $4.62B in Johnson & Johnson Talcum Powder Lawsuit

Posted 2 days ago in News for Health Professionals

FRIDAY, July 13, 2018 -- A jury says Johnson & Johnson must pay $4.62 billion to 22 women who allege they developed ovarian cancer after using the company's Baby Powder and Shower to Shower brand talcum powder as part of their daily feminine hygiene routine. The St. Louis jury announced their decision July 12 after weeks of hearing testimony and eight hours of deliberation. The award includes $550 million in... Read more

Fish Pedicure Causes Woman to Lose Toenails

Posted 2 days ago in News for Health Professionals

FRIDAY, July 13, 2018 -- A woman lost several toenails after a fish pedicure, according to a case report published online July 3 in JAMA Dermatology. Shari R. Lipner, M.D., Ph.D., from Weill Cornell Medicine in New York City, reports on a young woman presenting with nail abnormalities several months after a fish pedicure. An examination revealed that the proximal nail plate was discontinuous with the distal nail... Read more

Virtual Assistants Not HIPAA Compliant

Posted 2 days ago in News for Health Professionals

FRIDAY, July 13, 2018 -- Virtual assistant programs like Google Assistant, Siri, and Alexa are not yet in compliance with the Health Insurance Portability and Accountability Act (HIPAA), warns an article published in Medical Economics. While it is tempting for doctors to employ the technology for scheduling or note taking with a simple voice command, these technologies need additional advancements and protections to... Read more

100 Now Sickened by Salmonella-Tainted Honey Smacks Cereal

Posted 2 days ago in News for Health Professionals

FRIDAY, July 13, 2018 -- One hundred people across 33 states have now fallen ill with Salmonella after eating Kellogg's Honey Smacks cereal, according to the U.S. Centers for Disease Control and Prevention. Many of the illnesses linked to the Salmonella Mbandaka strain have been severe -- so far, 30 people have been hospitalized, although no deaths have been reported. The illnesses first surfaced in early March and... Read more

Did Legalization of Same-Sex Marriage Yield a Health Benefit?

Posted 2 days ago in Medical

FRIDAY, July 13, 2018 -- While the legalization of same-sex marriage improved gay men's chances of having both health insurance and access to health care, it didn't translate into better health, a new study suggests. "We found that lesbian, gay or bisexual adults were more likely to get married after having access to legal same-sex marriage," said study co-author Gilbert Gonzales Jr., an assistant professor of... Read more

Many Young Kids Not Screened for Developmental Delays

Posted 2 days ago in Medical

FRIDAY, July 13, 2018 -- Doctors are supposed to screen young children to see if they're learning basic skills. But only 17 percent of kids get this critical testing in some places in the United States, a new study finds. Overall, fewer than one-third of U.S. children under 3 years old receive recommended screening for developmental problems, said researchers at John Hopkins University in Baltimore. And they found... Read more

Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA

Posted 3 days ago in New Drug Applications

THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Evenity™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Evenity increases bone f... Read more

Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer

Posted 4 days ago in New Drug Approvals

PRINCETON, N.J.-- July 11, 2018 (BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient... Read more

FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)

Posted 13 days ago in New Drug Approvals

RALEIGH, N.C., July 3, 2018 -- Merz North America announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. Xeomin is the first and only neurotoxin with this approved indication in the U.S. “Until now, there has not been an F... Read more

FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia

Posted 13 days ago in New Drug Approvals

DUBLIN, July 2, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Aristada Initio (aripiprazole lauroxil) for the initiation of Aristada (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. For the first time, Aristada Initio, in combination with a single 30 mg dose of oral... Read more

Dermira Receives FDA Approval for Qbrexza (glycopyrronium) Cloth to Treat Excessive Underarm Sweating

Posted 2 weeks ago in New Drug Approvals

MENLO PARK, Calif., June 29, 2018 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved Qbrexza (glycopyrronium) cloth, an anticholinergic indicated... Read more

FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia

Posted 2 weeks ago in New Drug Applications

June 27, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of ... Read more

Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER

Posted 2 weeks ago in New Drug Applications

AUSTIN, Texas, June 26, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 14 to 3 against the approval of Remoxy ER (oxycodone extended-release capsules) for the... Read more

Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.

Posted 3 weeks ago in New Drug Applications

NEW HAVEN, Conn.--(BUSINESS WIRE) June 19, 2018 --Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The submission uses a rare disease p... Read more

FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion

Posted 3 weeks ago in New Drug Applications

LAVAL, Quebec, June 18, 2018 /PRNewswire/ -- Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for Duobrii1 (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque... Read more

BioSight Launches a Phase 2b Clinical Trial of BST-236 as a First-Line Treatment of Acute Myeloid Leukemia

Posted 5 days ago in Clinical Trials

AIRPORT CITY, Israel, July 11, 2018 /PRNewswire/ -- BioSight Ltd., a pharmaceutical development company focused on the development of targeted oncology drugs, announced today that it has received the FDA and the Israeli Ministry of Health clearance to launch a Phase 2b clinical trial of BST-236 for treatment of Acute Myeloid Leukemia (AML). The trial, which will be launched in the upcoming month, will be... Read more

Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health

Posted 5 days ago in Clinical Trials

IRVINE, Calif., July 11, 2018 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age, announced today that results from a human clinical study of Niagen®, a novel form of vitamin B3, at University of Copenhagen and Aarhus University Hospital, were published yesterday in The American Journal of Clinical Nutrition. The study was ... Read more

Vidac Pharma Announces Initiation of Phase 2b Clinical Trial of VDA-1102 Ointment in Patients with Actinic Keratosis

Posted 6 days ago in Clinical Trials

Jerusalem, Israel, July 10 2018 – Vidac Pharma, a clinical stage oncology and dermatology focused pharmaceutical company, today announced initiation of a Phase 2b clinical trial of VDA-1102 ointment to treat subjects with actinic keratosis (AK), an early stage of cutaneous squamous cell carcinoma (cSCC), which is a common form of non-melanoma skin cancer. VDA-1102 is a selective allosteric modulator that triggers a... Read more

miRagen Therapeutics Announces Initiation of Phase 2 Clinical Trial of MRG-201

Posted 6 days ago in Clinical Trials

BOULDER, Colo., July 10, 2018 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced the initiation of a Phase 2 clinical trial to evaluate MRG-201 in subjects with a predisposition for keloid formation. miRagen is developing MRG-201, a synthetic mimic of microRNA-29 for the potential... Read more

Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma

Posted 6 days ago in Clinical Trials

MADISON, Wis., July 09, 2018 (GLOBE NEWSWIRE) -- Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug C... Read more